| Eligibility |
Inclusion Criteria:
1. Able to read, understand, and willing to sign an informed consent form (ICF) and
complete questionnaires written in English.
2. Generally healthy male or female adults, = 21 years of age, inclusive, at the time of
consent.
3. Positive urine cotinine test at the Screening Visit.
4. CC or HTP is the primary form of tobacco- or nicotine-containing products used within
30 days of the Screening Visit. Subjects may be users of other tobacco- or
nicotine-containing products. If the subject is a dual/poly user of tobacco- or
/nicotine-containing products then the subject must self-report that a CC or HTP is
their primary product.
5. Must have used 5 or more CCs or HTP sticks per day over the last 30 days. Brief
periods of abstinence due to illness, quit attempt (prior to 30 days of the Screening
Visit), or clinical study participation (prior to 30 days of the Screening Visit) will
be allowed at the discretion of the Principal Investigator (PI). Dual users of CCs and
HTPs (either 5 CCs or 5 sticks per day or a combination of 5 products per day) will
also be allowed into the study.
6. Males must use an acceptable method of birth control from Visit 1 until the end of the
study, unless they have had a vasectomy or are abstinent from heterosexual intercourse
(as a lifestyle choice, not just for the purpose of study participation), or their
female partner is not able to bear children.
7. Females must be willing to use a form of contraception acceptable to the PI from the
time of signing informed consent until the end of the study.
Examples of acceptable means of birth control are, but not limited to:
1. Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion,
bilateral oophorectomy, bilateral salpingectomy);
2. Established use of oral, implantable, injectable or transdermal methods of
contraception associated with inhibition of ovulation;
3. Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with
spermicide;
4. Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g.,
Mirena or Kyleena);
5. Vasectomized partner;
6. Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the
purpose of study participation); and
7. Post-menopausal and not on hormone replacement therapy.
8. Must be willing to use the assigned IP and only the assigned flavor as their primary
source of nicotine use for the full duration of the 28-day ambulatory period. Use of
other non-CC or non-HTP tobacco/nicotine-containing products (e.g., ENDS products
(e-cigarettes), snuff, snus, chewing tobacco, modern oral pouches) will be permitted
during the ambulatory period.
9. Must have familiarity with modern electronic devices such as an IOS/Android smart
phone or tablet computer ("tablet") and be willing to be provided with an electronic
device, that allows for both Bluetooth connectivity and internet connectivity. Must be
willing to use an application on the electronic device and keep the application active
for the length of the study
10. Able to safely perform the required study procedures, as determined by the PI.
Exclusion Criteria:
1. Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal,
hepatic, endocrine, gastrointestinal, psychiatric, hematological, or neurological
disease, or any other concurrent disease or medical condition that, in the opinion of
the PI, makes the study participant unsuitable to participate in this clinical study.
2. History of, presence of, or clinical laboratory test results indicating diabetes.
3. Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg,
measured after being seated for five minutes.
4. Scheduled treatment for asthma currently or within the past consecutive 12 months
prior to the Screening Visit. As-needed treatment, such as inhalers, may be allowed at
the PI's discretion, pending written approval from the Medical Monitor.
5. Any history of cancer, except for primary cancers of skin such as localized basal
cell/squamous cell carcinoma that have been surgically and/or cryogenically removed.
6. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C virus (HCV).
7. Use of any medication or substance that aids in smoking cessation, including but not
limited to: NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®),
bupropion (Wellbutrin®, Zyban®), or lobelia extract within (=) 30 days prior to
signing the ICF.
8. Participation in another clinical trial within (=) 30 days prior to signing the ICF.
The 30-day window for each subject will be derived from the date of the last study
event in the previous study to the time of signing the ICF in the current study.
9. Females who have a positive pregnancy test, or who are pregnant, breastfeeding, or
intend to become pregnant during the course of the study.
10. Subjects = 35 years of age currently using systemic, estrogen-containing contraception
or hormone replacement therapy.
11. A positive urine drug screen without evidence of prescribed corresponding concomitant
medication(s) at the Screening Visit or Enrollment Visit.
12. Postpones a decision to quit using tobacco- or nicotine-containing products in order
to participate in this study or a previous attempt within (=) 30 days prior to signing
the ICF.
13. Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol
test result at the Screening Visit or Enrollment Visit.
14. Employed by a tobacco or nicotine manufacturing company, the study site, or handles
tobacco- or nicotine-containing products as part of their job.
15. Determined by the PI to be inappropriate for this study.
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